The FDA says it is not known what factor or combination of factors contributed to chondrolysis, but it is believed that the infused local anesthetic or the device materials may have contributed to the condition. Prior to 2000, reports of chondrolysis were low, but reports of PAGCL began to appear more frequently in recent years as surgeons began using newer devices and newer techniques, such as continuous postoperative infusion of anesthetics into the glenohumeral joint in the shoulder.

The FDA informs health care professionals that elastomeric infusion devices are safe when used properly; however, use of pain pumps has not been approved for use in shoulder surgery. The agency now requires pain pump manufacturers to warn health care providers and their patients about the potential for severe joint damage when these devices are used for intra-articular anesthetic administration.

The FDA advises nurses and other health care professionals when treating patients who will or have used elastomeric infusion devices for shoulder surgery to make sure the patient has given informed consent and understands the potential risks and benefits; teach the patient to immediately report signs and symptoms of chondrolysis such as chronic severe joint pain, stiffness, loss of motion, weakness in the shoulder, or popping, grinding or clicking of the shoulder joint; and prepare patients who have signs and symptoms of chondrolysis for additional diagnostic studies, such as X-rays or magnetic resonance imaging, as ordered.

In conclusion, the FDA urges health care professionals to “be vigilant to help patients avoid complications or get further treatment when needed.”

SOURCE: Pain Pumps › FDA offers shoulder pain pump safety tips to nurses

Pain pumps

Pain pumps, also known as infusion pumps, are devices that feed a steady flow of anesthetic into the surgical space following surgery. The devices fell under strict review by the Food and Drug Administration (FDA) after numerous reports of chondrolysis were reported in patients who had used the pumps, leading the agency to launch the Infusion Pump Improvement Initiative to address infusion pump safety problems.

Chondrolysis is a condition in which the cartilage in the joint space wears away causing bone to rub against bone. It causes severe pain and loss of motion. There is no cure for chondrolysis other than total shoulder replacement.

While the pumps may be beneficial in surgeries such as “tummy tuck” procedures, they have been proven unsafe for shoulder surgeries and in fact were never even approved by the FDA to be used in that manner. But that didn’t stop pain pump manufacturers from instructing surgeons to use the pumps in shoulder surgeries. As a result, hundreds of chondrolysis sufferers have filed lawsuits against pain pump manufacturers claiming they were not adequately warned of the risk of developing chondrolysis.

SOURCE: Pain Pumps › Pain pumps cause problems for shoulder surgery patients

Pain pumps are balloon-like devices that are filled with anesthetic and rest outside the body. During surgery, a catheter from the pain pump is placed inside the surgical site and delivers pain medication directly to the joint space. This use of pain pumps in shoulder surgery became popular in the 1990s after manufacturers instructed surgeons to use the pumps in this manner. However, this use was never approved by the Food and Drug Administration (FDA), and soon complications began to arise.

Doctors were baffled at first to see so many former shoulder surgery patients coming back with even more pain than before. It didn’t take long for doctors to make a connection between pain pumps, anesthetics and debilitating shoulder chondrolysis. One likely theory is that the anesthetic delivered directly to the shoulder joint caused the cartilage to wear away in many people.

Treatment for chondrolysis is challenging, says Ortho Super Site. Nonsteroidal anti-inflammatory drugs, intra-articular corticosteroids, and hyaluronic acid may provide some relief but ultimately, most sufferers may need total shoulder replacement surgery.

SOURCE: Pain Pumps › Pain pumps likely cause of shoulder chondrolysis

But beginning in the 1990s, orthopedic surgeons began seeing more and more patients who were complaining of limited range of mobility, pain and stiffness in their shoulder. Tests showed the cartilage was beginning to or had completely worn away causing bone to rub against bone, also known as chondrolysis. Doctors were baffled.

What they soon discovered is that all the patients who were developing or had developed chondrolysis had had shoulder surgery during which a pain pump was used to deliver anesthetics for 48 to 72 hours following surgery. The pain pumps were a new offering for surgeons who previously prescribed IV or oral painkillers to patients to help deaden the pain of shoulder surgery.

Pain pumps are balloon-like devices filled with anesthetic that rests outside the body. The anesthetic is administered directly into the joint space through a catheter, which is removed after the medication has been used. Pain pump manufacturers were quick to promote this new use of pain pumps to doctors in the 1990s even though the use was never approved by the Food and Drug Administration (FDA).

What doctors didn’t realize at the time is that the pain pumps, which dripped medicine directly into the joint space, were causing the cartilage in the shoulder to wear away. Doctors soon made the connection between pain pumps and shoulder chondrolysis. Last year, after studies on shoulder chondrolysis had been published in several medical journals, the FDA issued a warning to doctors informing them that pain pumps should not be used during shoulder surgery and that this use has never been approved by the agency.

SOURCE: Pain Pumps › What is Chondrolysis of the shoulder?

While this use of pain pumps was a convenient way to relieve pain from surgery, it also resulted in a surprisingly high number of cases of a painful and debilitating deterioration of cartilage in the shoulder joint known as chondrolysis, specifically Postarthroscopic Glenhumeral Chondrolysis (PAGCL). The condition is permanent and many who suffer from it require shoulder replacement surgery.

Last year, the Food and Drug Administration (FDA) issued a notice to health care professionals informing them that use of pain pump devices and anesthetics in shoulder surgery were never approved by the agency. Yet, knowing this, pain pump manufacturers still instructed surgeons to use the pumps in this manner. As a result, a surprisingly high numbers of cases of chondrolysis were reported by patients who had used the pain pumps. As many as 63 percent of patients who used shoulder pain pumps are at risk of developing chondrolysis.

Several shoulder pain pump lawsuits have been filed by people who allege that they developed chondrolysis because the manufacturers of pain pumps failed to notify the medical community about the possible harm the devices could cause. More lawsuits are expected to be filed as more victims of these devices are diagnosed.

SOURCE: Pain Pumps › Studies link shoulder chondrolysis to pain pump devices

Gregg Zaun

Shoulder surgeries among professional baseball players are about as common as foul balls but they don’t always end careers. Zaun injured his shoulder in April when he collided on a plate, but opted to play through the pain. Last month in Pittsburgh, Zaun aggravated the injury while batting. The surgery will repair a torn labrum.

Labrum repair surgeries are not uncommon and can often return players to the field after rehabilitation. But not all patients have been as lucky. Last Fall, the Food and Drug Administration (FDA) issued a warning to health care professionals that during such surgeries, pain pumps should not be used.

Pain pumps are balloon-like devices that are filled with anesthetics and rest outside the body. In many instances, a catheter is placed inside the cartilage at the surgical site, where it drips medication for up to 72 hours. This use has never been approved by the FDA, but pain pump manufacturers instructed surgeons to use them in this manner. As a result, numerous people who had shoulder repair surgeries began complaining of stiffness, a decreased range of motion, and pain. Doctors found that the cartilage in these patients’ shoulders had worn away, causing bone to rub against bone. This painful, debilitating and irreversible condition is known as chondrolysis.

Source: The Canadian Press

SOURCE: Pain Pumps › Zaun to undergo season-ending shoulder surgery

“We certainly knew that it was a possibility. We went through the rehab process in a very methodical way to give us the best chance to get him back on the mound, and it didn’t work,” executive vice president of baseball operations Andrew Friedman told USA Today. ”But in the meantime, we strengthened up the shoulder through the rehab process, which we feel like will aid in the recovery. And by all indications, (the surgery) went really well.” Howell is expected to recover in time to play during the 2011 season.

For some, however, shoulder surgery can exacerbate the injury. In the late 1990s, surgeons were told by the manufacturers of pain pumps that the devices could be used effectively in place of oral or IV painkillers. This reduced hospital stays and was to speed up the recovery process. However, doctors began seeing patients who underwent shoulder surgery but then developed a painful and debilitating condition known as chondrolysis in which the cartilage in the shoulder wears away causing bone to rub against bone.

It didn’t take long for doctors to realize that it was the pain pumps that were causing the chondrolysis. What was even more shocking is that the use of pain pumps in the manner in which pain pump manufacturers were telling doctors to do was never approved by the Food and Drug Administration (FDA). Last year, the FDA issued a notice to health care providers informing them that the pain pumps should not be used in shoulder surgery and that the use has never been approved.

SOURCE: Pain Pumps › Tampa Bay Rays’ Howell undergoes season-ending shoulder surgery

I-Flow

I-Flow had tried to prevent evidence from being included in the trial that would have been used to form the basis of punitive damage claims. That evidence allegedly included information that I-Flow’s chief executive officer was advised, prior to the plaintiffs’ injuries, to issue a warning that the pumps should not be used for shoulder surgery. Instead, I-Flow continued to instruct surgeons to use the pain pumps with local anesthetics for shoulder surgery, a use that was never approved by the Food and Drug Administration (FDA).

In November 2009, the FDA required manufacturers of pain pumps as well as the makers of local anesthetics used in the devices to add new warnings about the risk of chondrolysis. The warnings also alerted health care professionals not to use the pumps with local anesthetics.

There are at least 150 shoulder pain pump lawsuits pending against I-Flow and other manufacturers of pain pump devices from plaintiffs who allege that the devices caused them to develop chondrolysis of the shoulder. All lawsuits claim the manufacturers failed to warn patients and their doctors of the risk of chondrolysis.

SOURCE: Pain Pumps › I-Flow settles lawsuits from plaintiffs injured by shoulder pain pumps

Matthew was a physically active individual who suffered a minor tear in his right bicep tendon his while throwing a football. Following surgery to repair the tear, Matthew’s condition worsened. Matthew’s surgeon had implanted a pain pump device to deliver pain medication directly into the shoulder joint for up to 72 hours following surgery, following a method that was instructed to surgeons by pain pump manufacturers.

However, the constant drip of anesthetic into the shoulder joint was found to wear down the cartilage in the shoulder joint, resulting in a painful and debilitating condition known as chondrolysis. In November 2009, as more cases of chondrolysis in shoulder joints surfaced, the Food and Drug Administration (FDA) issued a warning to health care professionals that it had never approved such use of pain pumps in shoulder surgeries.

Jurors awarded Beale $1.275 million in economic damages and $3 million in non-economic damages. His wife, Krista Beale, was awarded $1.2 million in loss of consortium damages.

Source: The Medical News

SOURCE: Pain Pumps › Oregon appeals court denies I-Flow request for retrial

Shoulder chondrolysis is a condition that more and more people who have had previous shoulder repair surgery have been diagnosed with. It was the surgeons who first realized that what caused these patients to develop the serious shoulder ailment was the pain pump device used during and after surgery to deaden pain in the shoulder joint. Doctors later learned that pain pump manufacturers were instructing surgeons to use the devices in a manner that was not approved by the Food and Drug Administration (FDA). Unfortunately, there is no cure for chondrolysis and many patients who suffer from the condition must undergo shoulder replacement surgery.

For Justin, relief came in November 2008, when he had a humeral head transplant. The surgery was performed by Dr. Brian Cole with The Cartilage Restoration Center at Rush. Since then, Justin’s right arm mobility has been restored and he is back to living an active lifestyle.

Source: Life Active with Rush

SOURCE: Pain Pumps › Chondrolysis sufferer finds relief with humeral head transplant

Shoulder surgery

Andrews performed surgery on Guzman’s shoulder in July 2003. Experts say that a full recovery from a second surgery is unlikely. But shoulder pain this spring has kept the pitcher off the mound despite strengthening exercises over the off season. Surgery may be his only hope.

“I don’t think there’s a chance to get it fixed without the surgery,” Guzman said. “By doing rehab, it won’t do anything. I spent four months here working out and I felt as strong as ever and there’s still pain. I think that’s the only way to get it fixed.”

For professional athletes in particular, shoulder surgery is nothing to take lightly. The injuries alone can be enough to end careers, but for some, surgery to repair shoulder injuries has resulted in serious problems. One such problem comes from the use of pain pumps, devices used to inject pain medication directly into the shoulder joint for up to 72 hours following shoulder surgery. That medication was found to have caused the breakdown of cartilage in the shoulder joint, causing bone to rub against bone. This painful and irreversible condition is known as chondrolysis.

SOURCE: Pain Pumps › Cubs pitcher considers pros, cons of shoulder surgery

Michael Johnson

Johnson is suing Moog Inc., Stryker Corp. and Stryker Sales Corp., McKinley Medical, Curlin Medical and Linvatec Corp. for economic, non-economic and punitive damages resulting from use of his pain pump.

Pain pumps are balloon-like medical devices filled with medication that rest outside the body. The device has a catheter that is placed into the shoulder area and feeds medication to the surgery site for up to 72 hours. When all the medication has been used, patients simply pull the catheter out of the body. While the pain pumps have reduced hospital stays and provided relief immediately following shoulder repair surgeries, the long-term effects can be dangerous. The anesthetic used in the pain pumps eats away at the cartilage in the shoulder joint, leading to a debilitating condition known as chondrolysis.

Chondrolysis occurs when cartilage in the shoulder joint wears away causing bone to rub against bone. Those with chondrolysis have pain in the shoulder joint and limited mobility. Many require shoulder joint replacements.

Several people treated with pain pump devices following shoulder surgery have developed this once-rare condition, and many are joining Johnson in the fight against pain pump manufacturers for justice.

Source: The Southeast Texas Record

SOURCE: Pain Pumps › Another lawsuit filed against pain pump manufacturers

Arthritis in the shoulder is somewhat uncommon, with about 40,000 shoulder replacements being performed each year in the United States. By comparison, 450,000 knee and 230,000 hip replacements are performed annually. But the increasing reports of shoulder arthritis in young patients is alarming on many levels.

For starters, current shoulder replacement techniques do not adequately address the high function demands of young active patients. And while shoulder replacement may help relieve pain, many of these young patients who have shoulder replacement surgery will require further shoulder reconstructive surgery in the future.

The arthritic condition many of these young people suffer with is known as chondrolysis, a condition in which the cartilage in the shoulder joint wears away causing bone to rub against bone. There is no cure, and those who have chondrolysis often suffer from pain, limited mobility and debilitation. In many cases patients require shoulder replacement surgery.

As more and more reports of chondrolysis were being reported in patients following shoulder surgery, surgeons and researchers began to ask why. Laboratory data and clinical reports began pointing to the same likely culprit – the prolonged use of intra-articular local anesthetics administered directly into the shoulder joint by a pain pump device. Investigations found that this was not an FDA-approved use for the pain pump or the anesthetic; however, that didn’t stop pain pump manufacturers from instructing surgeons to use the device in such a way.

Surgeons are now understanding how they have been misled by the makers of pain pumps and with luck, the number of new chondrolysis reports will decrease in time. Until then, the only recourse victims have is to go after the pain pump manufacturers in court.

Source: Gerson Lehrman Group

SOURCE: Pain Pumps › Reports of young patients with arthritis in shoulder increasing

It is not known whether the drugs or the device is causing the chondrolysis, or if it is a combination of several factors. However, reports of the debilitating shoulder condition have skyrocketed in the past few years since pain pump devices were used in this fashion.

Chondrolysis is a serious condition that causes pain and loss of motion. Some patients may require joint replacement surgery. Many of the patients who have developed chondrolysis following shoulder repair surgery were adolescents or young adults.

In the patient safety announcement, the FDA is reminding health care professionals that use of local anesthetics in pain pump devices is not an approved use, and the FDA is requiring makers of local anesthetics to update the labeling of these drugs to include a warning of the risk of chondrolysis. Similar warnings will also be placed on pain pump devices.

Source: FDA Patient Safety Notice

SOURCE: Pain Pumps › FDA issues warning about local anesthetics, pain pumps

Since 2005, Dr. Bailie says he has seen dozens of patients come to him months after surgery with worsening pain and limited mobility. The diagnosis was chondrolysis, a condition in which the cartilage in the shoulder joint wears away leaving bone to rub against bone. There is no cure for chondrolysis and in some cases, total shoulder replacement is required.

But what could be causing his patients’ shoulders to worsen? Several studies began pointing to the same likely culprit – the pain pump device used during and after surgery to deliver medication into the joint space. As the anesthetic dripped onto the cartilage, the cartilage began wearing away over the course of weeks or months, sometimes longer.

Doctors soon realized that the way pain pump manufacturers were instructing them to use the devices was never approved by the Food and Drug Administration (FDA). In fact, the FDA had rejected the use on more than one occasion, saying more tests needed to be conducted to determine the safety of such use.

Now hundreds of patients injured by the pain pumps are suing manufacturers of the pain pumps, insisting the companies should have done more to warn surgeons of the potential risks. Lawyers say the manufacturers disregarded patient safety in an effort to bolster sales, but pain pump manufacturers argue more research is needed to determine if the cases of chondrolysis were actually caused by pain pump use.

SOURCE: Pain Pumps › Doctor ‘lost sleep’ over chondrolysis in patients

Whitney Moore

The condition caused Moore pain and limited mobility in her shoulder, and left her little choice but to close her business. She even has to asks friends to do small chores for her, like cut the crust of a piece of pie. “Until this injury, I was in pretty prime physical condition,” Moore told the New York Times. “It’s a whole flip of my world.”

Moore is one of hundreds of victims of what a handful of studies say is a condition caused by the use of pain pumps. The devices look like balloons that are filled with anesthetic that sit outside the body. Attached to the pump are catheters that are placed in the wound site during surgery to drip painkillers in the shoulder during and after surgery. After 48-72 hours, the medication runs out and the patient simply pulls the catheter out.

Doctors were advised by pain pump manufacturers to place the catheters directly into the joint space, but what doctors later learned is that that use of pain pumps was not approved by the Food and Drug Administration (FDA), and was, in fact, turned down on more than one occasion for further safety studies.

Pain pump manufacturers now find themselves embroiled in a mass of lawsuits claiming they are responsible for the serious injuries, which in some cases requires total shoulder replacements and often a lifetime of pain.

SOURCE: Pain Pumps › Woman’s life turns topsy turvy after shoulder surgery

The notice to patients was part of a recent announcement by the FDA warning health care professionals of the a painful and debilitating condition known as chondrolysis reported in patients who have had surgery followed by continuously infused local anesthetics for 48 to 72 hours through a pain pump device. The anesthetics involved are marketed as bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine and ropivacaine.

While the local anesthetics are approved by the FDA as injections for the production of local or regional anesthesia or analgesia, the approved drug labels for local anesthetics do not include an indication for continuous intra-articular postoperative infusions or use of infusion devices, such as pain pump devices, or elastomeric pumps.

Chondrolysis was diagnosed within a median of 8.5 months after infusion. Almost all of the reported cases (97 percent) occurred following shoulder surgeries. Joint pain, stiffness and loss of motion were reported as early as the second month after receiving the infusion. In more than half of these reports, the patients required additional surgery, including arthroscopy or arthroplasty, also known as joint replacement.

The numerous reported cases of chondrolysis following use of intra-articular infusion with local anesthetics has prompted the FDA to require the drug manufacturers to update their product labels to warn healthcare professionals about the potential serious adverse effect.

SOURCE: Pain Pumps › Orthopedic surgery patients urged to monitor symptoms

UCLA

Shoulder injuries among athletes is not uncommon and can bench a player for weeks or months. There was a time when such injuries that required surgery brought about career-ending fears, but technology over the years has made full recovery a more likely possibility. However, just a few years ago, surgery to repair the shoulder often was the cause of more serious injury.

A recent study published in The American Journal of Sports Medicine first brought to light the connection between chondrolysis, a condition in which the cartilage in the shoulder has been eroded away, and the use of pain pump devices during and following arthroscopic shoulder surgery. Pain pumps are balloon-like devices that hold local anesthetics. During surgery catheters that lead from the balloon area of the device are inserted into the surgical site. Pain medication is then administered for up to 72 hours following surgery. Once the medication has been used up, the patient simply pulls out the catheter.

Pain pumps are approved by the FDA with the catheter placed in the shoulder tissue. However, in the late 1990s, pain pump manufacturers began instructing surgeons to insert the catheter directly into the shoulder joint, allowing the medication to drip directly onto the cartilage, a use that was not FDA approved.

In the early 2000s, doctors became puzzled when more and more patients who had surgery to repair shoulder injuries – and who showed no signs of cartilage wear at the time of surgery – were suffering from pain and loss of motion, and were ultimately diagnosed with chondrolysis. It didn’t take long for doctors to make the connection between the debilitating chondrolysis and the use of pain pump devices.

Since the connection was made, the FDA and professional groups have instructed surgeons of the correct, FDA-approved use of shoulder pain pumps, making the surgery safer for patients. Meanwhile, the lawsuits against pain pump manufacturers are mounting.

SOURCE: Pain Pumps › UCLA’s Keefe benched due to shoulder injury, but recovery likely

A recent study published in The American Journal of Sports Medicine first brought to light the connection between chondrolysis, a condition in which the cartilage has been eroded away, and the use of pain pumps during and following surgery. This type of chondrolysis, characterized by the complete loss of articular cartilage from the humeral head and glenoid, has been associated with intra-articular injection of dye, and with the post-arthroscopy infusion of local anesthetic into the joint.

Sixty-six cases of chondrolysis associated with shoulder arthroscopy followed by the intra-articular pain pumps with local anesthetic were identified among men and women between the ages of 15 and 57. Fifty-five of those patients had normal joint surfaces at the time of arthroscopy. All patients who suffered from chondrolysis suffered from pain and loss of motion that began between 91 to 1,650 days following surgery.

While pain pumps are approved by the Food and Drug Administration (FDA) to deliver pain medication into the shoulder tissue, they are not approved for use with the catheters placed directly in the joint space, as pain pump manufacturers had instructed surgeons. It is believed this non-approved practice led the anesthetic to erode the cartilage in the shoulder.

SOURCE: Pain Pumps › Surgeons discuss characteristics of chondrolysis caused by pain pumps

Jean-Thenistor Pascal

Pascal said he dislocated his right shoulder three times during the fight and had to have his shoulder popped back into place at least once by one of his cornermen. Despite having to box stretches almost entirely with his left hand, and looking hurt and worn down in the last few rounds, Pascal prevailed, earning a unanimous victory from the judges.

“I know I have a lot of guts,” Pascal said after the fight. “I knew it and now I really know it. When it happened the first time I told myself I was finished, but I couldn’t pull out in front of these fans. No way was I going to quit.”

Pascal’s surgery involved the removal of a bone chip and repair to the shoulder labrum, according to a statement released by promoter Groupe Yvon Michel. Pascal has been ordered to rest his shoulder for three weeks followed by five or six weeks of rehabilitation before he will be allowed to resume normal training. Pascal is scheduled to meet the WBC interim champion Chad Dawson in 120 days, but he may need to postpone that meeting until his shoulder recuperates.

Shoulder repair surgeries are about 85-95 percent successful. But some patients have had lingering problems, including the developing of a painful and debilitation condition known as chondrolysis. It wasn’t until after 2000 that doctors began to make a connection between a type of chondrolysis known as Postarthroscopic Glenohumeral Chondrolysis and the use of intra-articular pain pumps used in surgery. Details of that discovery were later published by The American Journal of Sports Medicine, and numerous lawsuits from those who suffer from chondrolysis have since filed suit against the makers of pain pumps.

Source: Montreal Gazette

SOURCE: Pain Pumps › WBC boxing champ undergoes shoulder repair surgery

Pain pump manufacturers named in the lawsuit include Moog Inc., Stryker Corp., Orthofix Inc., Linvatee Corp, I-Flow Inc, Breg Inc., and DJO Inc.

A study published by The American Journal of Sports Medicine first brought to light the connection between PAGCL, a type of chondrolysis in the shoulder, and pain pumps used during shoulder repair surgery. As a result of that study, hundreds of lawsuits have been filed against manufacturers of pain pump devices and pharmaceutical companies as more and more victims begin to put the pieces together and realize they were unnecessarily harmed by the devices used to alleviate pain during shoulder surgery.

There is no cure for chrondrolysis. The condition causes continuous pain; weakness in the shoulder; clicking, popping or grinding in the shoulder; and/or decreased range of motion. Some who suffer from chondrolysis may require complete shoulder replacement.

Source: Buffalo Business Journal

SOURCE: Pain Pumps › More lawsuits filed against pain pump manufacturers

On Friday, the FDA notified health care professionals of 35 reports of chondrolysis in patients who received regular infusions of the anesthetics for up to 72 hours following surgery. In the reported cases, the anesthetics were used with pain pump devices in which the medication was fed through a catheter that was placed directly into the joint space. The catheter was attached to a balloon that rested outside the body and was filled with the anesthetics.

These pain pump devices, often used with shoulder surgery, were approved by the FDA with the catheter placed in the shoulder tissue, not the joint space. But in the early 2000s, pain pump manufacturers began advising doctors to place the catheters directly into the joint space even though that use was not approved by the FDA. The constant drip of medication into the joint caused the serious breakdown of cartilage known as chondrolysis. Currently, patients who have been injured by the pain pump devices have filed suit against the manufacturers of pain pumps.

The anesthetics listed in the FDA notice include bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine and ropivacaine. These anesthetics are approved as injections for the production of local or regional anesthesia or analgesia. The approved drug labels for local anesthetics do not include an indication for continuous intra-articular postoperative infusions or use of infusion devices, such as elastomeric pumps. The FDA has not cleared any infusion devices with an indication for use in intra-articular infusion of local anesthetics.

The FDA is encouraging healthcare professionals to follow the instructions for use of elastomeric infusion devices, and to not use these devices for continuous intra-articular infusion of local anesthetics after orthopedic surgery.

SOURCE: Pain Pumps › FDA warns of chondrolysis risk with unapproved use of local anesthetics

It is Dr. Carrese’s opinion that “to do otherwise would be a failure of expected ethical and professional conduct, and in turn a failure of good clinical practice.”

The opinion addresses the “ethical and professional obligations of orthopedic surgeons to patients who have had arthroscopic shoulder surgery in conjunction with postoperative use of a pain pump device that infuses medication continuously via a catheter directly into the shoulder joint and who are therefore at risk for developing severe pain and disability of the shoulder joint secondary to a condition known as chondrolysis.”

Dr. Carrese is an Associate Professor of Medicine and Director, Program on Ethics in Clinical Practice, at Johns Hopkins Berman Institute of Bioethics, Johns Hopkins University.

This recommendation follows a report from the FDA distributed today to health care professionals following a review of 35 reports of chondrolysis (necrosis and destruction of cartilage) in patients given “continuous intra-articular infusions of local anesthetics with elastomeric infusion devices to control post-surgical pain.” According to the study, 97 percent of the reported cases of chondrolysis followed shoulder surgeries.

The FDA report says early adverse affects following pain pump use after surgery included joint pain, stiffness, and loss of motion, occurring as soon as two months after surgery. In half the reported cases, the FDA report notes, patients required additional surgery, including arthroscopy or arthroplasty (joint replacement).

A number of lawsuits have been filed on behalf of patients suffering from chondrolysis as a result of pain pumps being inserted directly into the cartilage rather than into the muscle tissue following surgery. The FDA only approved pain pump use as inserted in the muscle tissue, but the lawsuits allege pain pump manufacturers marketed the devices to physicians with instructions to insert the catheter into the joint for faster and more efficient pain relief.

However, studies show that introducing the anesthetic medications directly into the joint in this manner destroys the cartilege and results in chondrolysis.

Read the Ethics Recommendation Letter.

Read the FDA Report.

SOURCE: Pain Pumps › Doctors have obligation to tell former patients about pain pump risks

Shoulder injuries are not uncommon among athletes. Hard and repetitive throwing motions like those needed for football and baseball leave many players with shoulder problems, many of which require surgery. While a full recovery is usually possible, some patients’ injuries were worsened by shoulder surgery.

The phenomenon even confused doctors who performed the shoulder repair surgeries. They were finding a growing number of patients months or years after surgery were back in their offices complaining of pain, stiffness and loss of motion. Upon further inspection, doctors found those patients had developed a condition known as chondrolysis, caused by the breakdown of cartilage. As the cartilage wears away, bone begins to rub against bone causing even more pain and damage.

What doctors finally deduced was that it wasn’t the surgery that was causing this specific type of chondrolysis known as postarthroscopic glenohumeral chondrolysis (PAGCL), but the pain pump used during and after surgery. The pain pumps are devices that have a balloon filled with pain-deadening medication. That medication is fed directly into the wound site through a catheter for up to 72 hours.

The pumps were approved by the Food and Drug Administration (FDA) with the catheter placed in the shoulder tissue. But pain pump manufacturers began telling doctors to place the catheters in the shoulder joint, which allowed the joint space to be bathed in medication. What doctors didn’t realize is that constant drip of medication into the shoulder joint was slowly eating away at the cartilage, resulting in chondrolysis.

Since this discovery, published in a recent issue of The American Journal of Sports Medicine, patients who have suffered serious disability from the wrongful use of pain pumps have sued the manufacturers of pain pumps. If you are experiencing the symptoms associated with chondrolysis or PAGCL, you too may have a claim against the manufacturer.

Source: St. Petersburg Times

SOURCE: Pain Pumps › FSU quarterback faces shoulder repair surgery

Lawsuits

Pain pump manufacturers, such as I-Flow, Don Joy, Stryker, Moog, and Breg, to name a few, dismiss the claims that their products have caused numerous people harm. But by 2006, physicians and scientists clearly began to see the connection between the shoulder pain pumps and chondrolysis.

At issue was the placement of the pain pump’s catheter directly into the joint space, a use that was promoted by the devices’ manufacturers but not approved by the Food and Drug Administration (FDA). The constant and steady dripping of anesthetic drugs such as Marcaine, bupivacaine and ropivacaine into the shoulder joint for up to 72 hours after surgery gradually ate away at the cartilage. In most cases, it was months or years before patients began experiencing the serious symptoms of chondrolysis.

There is no cure for chondrolysis, and in some cases shoulder replacement surgery is required. Yet pain pump manufacturers say they are not liable despite aggressively promoting the devices for joint surgeries of the shoulder as well as the knee, ankle and foot.

No lawsuits have yet gone to verdict. Some have reached confidential settlements. But plaintiff victims are focused on 2010 as the year when justice is served.

SOURCE: Pain Pumps › Pain pump victims seek justice against manufacturers

Some rotator cuff disorders – especially the early stages of rotator cuff damage –  may be treated without surgery through rest and rehabilitation, ice and heat applications, anti-inflammatory medications, and physical therapy. Situations that may require surgery include symptoms that persist for more than 6 months, injuries that occurred suddenly, or if the tear is causing weakness.

Such injuries that may require surgery are those from a major sports injury or auto accident. Very large rotator cuff tears – larger than 2 inches – and tears that affect more than one of the four rotator cuff tendons sometimes cannot be repaired. But surgery may be able to relieve pain by removing damaged tissue from the joint.

Surgery, however, cannot always completely resolve problems with regular wear-and-tear over the years. And whether you choose to have surgery or not, rehabilitation and physical therapy will be required to get your shoulder back to near-par.

Surgery risks include infection, persistent pain, slow healing followed by stiffness, and the potential need for more surgery. In some cases, surgery may cause irregular heat rhythms, changes in blood pressure and heart attack.

Patients who have had shoulder surgery in the past have also suffered from a condition in which the cartilage has worn away, called chondrolysis. This condition was found to have been caused by a pain pump device that was implanted in patients following surgery to help relieve pain for up to 72 hours following surgery. If you have had shoulder surgery and are still experiencing pain and limited mobility, or have been diagnosed with chondrolysis, you may have a claim against the manufacturer.

SOURCE: Pain Pumps › Weigh pros, cons of shoulder surgery

Rotator cuff surgery

KFx Medical Corporation was awarded a patent this week by the U.S. Patent and Trademark office for knotless surgery tissue fixation. The key patent covers a broad range of methods used to perform surgical knotless tissue fixation, including the double row tissue repair technique used to restore the rotator cuff to its correct anatomic position.

The new knotless surgery tissue fixation is designed to eliminate knot tying and thus reduce the overall surgical time, which may aid in the healing process. Recovery from rotator cuff surgery is slow and can be painful. To help manage pain, surgeons often implant a pain pump into the shoulder tissue that delivers a steady amount of medication to the surgical site for up to 72 hours following surgery.

Pain pumps offer an alternative to narcotics and speed healing time, though they are not without fault. Shoulder pain pumps have been linked to a painful and debilitating shoulder condition known as chondrolysis in which the cartilage wears away leaving bone to rub against bone. As a result, manufacturers of shoulder pain pumps are facing hundreds of lawsuits filed by individuals injured by the pain pumps.

Sources: eHealthMD, Reuters

SOURCE: Pain Pumps › New rotator cuff surgery method can help reduce surgical time, effort

I-Flow Corp

I-Flow currently faces 212 lawsuits from people who claimed they were harmed by the company’s ON-Q pain pumps used for shoulder surgery, yet the company says it is optimistic that it can skirt the claims made against it. The most damning evidence includes a recent study published by The American Journal of Sports Medicine that identified intra-articular pain pumps as the likely cause of a condition known as chondrolysis. Postarthroscopic Glenohumeral Chondrolysis (PAGCL) is a specific type of chondrolysis associated with shoulder pain pumps.

PAGCL is a painful and debilitating condition in which the cartilage in the shoulder wears away causing bone to rub against bone. It can greatly decrease range of motion and cause weakness in the shoulder. There is no cure for PAGCL, and in severe cases, shoulder replacement surgery is required.

I-Flow’s total revenue for the first six months of 2009 increased 7 percent to $68 million, up $4.3 million over the first six months of 2008. First six month sales of the company’s On-Q product lines increased 5 percent, or $2.2 million, compared to the first six months of 2008. I-Flow projects a yearly revenue of $139.7 million to $146 million, over analysts’ average expectation of $138 million.

Sources:
Fox Business
Orange County Business Journal

SOURCE: Pain Pumps › I-Flow enjoys profits amid spike in product liability lawsuits

Chondrolysis is a rare condition in which the cartilage in a joint wears away causing bones to rub against bones. It was often seen in the hip where conditions such as birth defects caused the bones to rub against each other. This grinding of bones causes inflammation and pain and, eventually, destruction of the bones. It is painful and debilitating to those who suffer from this permanent condition.

In the 1990s, doctors began seeing chondrolysis in the shoulder, a place where it was rarely, if ever, seen before. As doctors began diagnosing more and more shoulder chondrolysis, also known as postarthroscopic glenohumeral chondrolysis (PAGCL), in patients who had previously had shoulder surgery, they began to make a connection between PAGCL and a new surgical use of pain pump devices used to manage pain following surgery.

That new use was to place the catheter of the pain pump directly into the shoulder joint rather than into the shoulder tissue. The constant drip of medication into the shoulder joint ate away at the cartilage in the shoulder.

It was the pain pump manufacturers who advised doctors to place the catheters directly into the joint space – a use that was not approved by the Food and Drug Administration. As a result, those manufacturers are facing hundreds of lawsuits against people who are suffering with PAGCL, a condition that is permanent and often requires shoulder replacement surgery.

SOURCE: Pain Pumps › Pain pumps blamed for painful chondrolysis in shoulder joints

Pain pumps

The devices take the place of narcotics, which carry a laundry list of side effects from nausea to vomiting to constipation and decreased sleep. They also require more monitoring and may require the patient to have a longer stay in the hospital.

“It may be $2,000 a day to have a patient stay in the hospital, so in this era of trying to reduce health care costs, if we can reduce their hospitalization from three days to one – or even better, to discharge them on the day of the surgery as an outpatient – we’ve dramatically changed the cost of that shoulder replacement or other major surgery,” said Randall Malchow, director of the Regional Anesthesia and Acute Pain Fellowship at Vanderbilt University. Dr. Malchow discussed the benefits of pain pumps for ABC 7 News.

The biggest risk these days with shoulder pain pumps is that in some cases, the pump does not work. That requires the patient to be admitted to the hospital and have pain medications administered by doctors and nurses. There is also a slight risk – about 1 percent – of infection. Pain pumps can be used for shoulder, elbow, wrist, knee and hip replacements.

The risks have recently improved since doctors began to make a connection between an alternative use of pain pumps and a painful and debilitating condition known as chondrolysis. Chondrolysis is when the cartilage in the joint has worn away and bone begins to rub against bone.

For years in the late 1990s and early 2000s, manufacturers of pain pumps began telling doctors to implant the pumps’ catheters directly into the shoulder joint rather than into the shoulder tissue. Inserting the catheter into the shoulder joint was not an FDA-approved use, as was placing the catheter in the shoulder tissue. By placing the catheters into the joint space, the medication dripped directly onto the cartilage and began eating away at it. The result? Pain, loss of motion, and limited use of the shoulder.

Today, doctors are using pain pumps as the FDA had intended – with the catheters placed in the shoulder tissue, with few risks. However, many of those who suffered because the pain pump manufacturers gave the surgeons ill advice have slapped the manufacturers with hundreds of lawsuits seeking justice.

SOURCE: Pain Pumps › Pain pumps less risky these days

The pain pumps eliminate the need for narcotics and costly hospital stays, and revolutionized pain management for procedures such as shoulder surgery. However, pain pumps didn’t always prove to be the best solution.

The pain pumps were first approved by the Food and Drug Administration (FDA) with the catheters feeding into the shoulder tissue. However, in the 1990s, the manufacturers of pain pumps asked the FDA to approve an alternative use – placing the catheters directly into the shoulder joint. The FDA required more testing before it would approve such a use. Rather than following proper protocol and running tests on the alternative use, the device manufacturers began advising surgeons to place the catheters in the shoulder joint.

Months and years later, doctors began noticing patients who had had shoulder surgery were beginning to suffer from a serious and debilitating condition known as chondrolysis in which the cartilage in the joint is worn away. Those doctors began to make the connection between patients with chondrolysis and the alternative use of the pain pumps.

Today, manufacturers of pain pumps are facing hundreds of lawsuits from people who have been injured by the devices. If you or a loved one has had shoulder surgery and now suffer from pain, weakness in the shoulder, decreased range of motion in the shoulder, or weakness in the shoulder, you may have a claim against the manufacturer.

Source: WCTV-TV

SOURCE: Pain Pumps › Shoulder pain pump makers face numerous lawsuits

Stryker Corporation, a multinational, publicly traded corporation, sells McKinley Medical pain products in the U.S., Canada and Mexico. Pain pumps are devices that deliver pain medication directly into the surgery site for up to 72 hours. The pumps were approved by the Food and Drug Administration (FDA) for use with the catheters inserted into the shoulder tissue; however, pain pump manufacturers, like Stryker, began advising doctors to place the catheters directly into the shoulder joint, which was not approved by the FDA.

When the pain medication dripped directly into the shoulder joint – where it was not FDA-approved to do – the medication ate away at the shoulder cartilage, resulting in a painful and debilitating condition known as chondrolysis. Soon physicians began making the connection between this use of pain pumps and chondrolysis. As a result, Stryker and other pain pump manufacturers are now facing hundreds of lawsuits from individuals injured by the devices.

During the same time that pain pump manufacturers were telling doctors to place the catheters of the devices into the joint space, it also began paying orthopedic surgeons for using the Stryker hip and knee replacement products, which is illegal. Questions still remain about whether doctors were also paid by Stryker to encourage other doctors to use Stryker products.

SOURCE: Pain Pumps › Pain pump manufacturer no stranger to controversy

Pain pumps

PAGCL is a painful and debilitating condition that occurs when the cartilage in the shoulder joint wears away, causing the bones to rub together. There is no cure for PAGCL. Some patients my require shoulder replacement surgery.

There are three medical device manufacturers at the crux of the shoulder pain pump controversy – Stryker Corporation, I-Flow Corporation, and DJO Incorporated. Stryker is a multinational, publicly traded corporation that sells the McKinley Medical LLP pain pump products in the U.S., Canada and Mexico. In 2006, the company reported net sales of almost $5.5 billion.

I-Flow’s family of products focuses on Regional Anesthesia, Intravenous (IV) Infusion Therapy, and Oncology Infusion Services. It’s acute pain management product line includes the ON-Q PainBuster Post-Op Pain Relief Sustem, The Soaker Catheter, and the C-bloc Continuous Nerve Block System. I-Flow has exclusive rights in the U.S. to distribute the On-Q PainBuster. In 2007, company recorded assets exceeding $81 million.

DJO is a global provider of solutions for musculosketal and vascular health that specializes in rehabilitation and regeneration products for the non-operative orthopedic, spine and vascular markets. The company manufactures and/or distributes the DonJoy Pain Control Device. In 2007, the company reported net assets of more than $173 million.

Allegations against the manufacturers include negligence, strict liability, warranty, and failure to warn physicians and patients of the risk of chondrolysis with use of the shoulder pain pumps. Those who have been injured by shoulder pain pumps are advised to seek legal counsel, as they may have a case against the manufacturer.

SOURCE: Pain Pumps › Three pain pump manufacturers at crux of controversy

Pain pumps

Pain pumps are often used in shoulder surgery and work effectively when used as approved by the Food and Drug Administration (FDA), with the catheter implanted in the shoulder tissue. However, in the early 2000s, pain pump manufacturers began advising physicians to insert the catheter directly into the shoulder joint, a method not approved by the FDA. When pain pumps were used in this manner, medication dripped directly into the shoulder joint, slowly eating away at the cartilage. Patients began experiencing a painful and debilitating condition known as chondrolysis.

As a result, numerous lawsuits have been filed against the manufacturers of pain pumps by individuals injured by the devices. But aren’t the companies that supplied the drugs used in the pain pumps also liable?

“They are, when you can find them,” says Frank Woodson, shareholder with Beasley Allen Law Firm. “One of the issues that I think that the attorneys representing pain pump victims are seeing is that is that the hospitals and/or surgical centers, wherever you had the surgery performed, sometimes do not do the best jobs of tracking what medications they placed into the pumps. I can tell you for a fact from the medical and billing records that sometimes it is impossible to determine who manufactured the medicine.”

If the manufacturer can be determined, “It is likely they are going to be added as a defendant because they knew from the medical literature that their medicine was toxic to cartilage,” Woodson says. “If they knew that their medicine was going to be used in pain pumps that were being placed intra-articularly into that joint space, then they’re just as liable as the pain pump manufacturers.”

SOURCE: Pain Pumps › Are drug companies to blame for shoulder pain pump injuries?

Pain pumps

“I think what we’re seeing is that physicians are finally seeing the relationship between pain pumps and chondrolysis – especially since the first lawsuits were filed a couple years ago,” says Frank Woodson, shareholder with Beasley Allen Law Firm. “In addition, literature is now being published about the connection between pain pumps and chondrolysis. The more information that becomes available, the more people are learning what may be causing their shoulder problems.”
Chondrolysis is a condition in which the cartilage in the joint wears away, resulting in loss of mobility and pain. Over the past few years, surgeons began seeing several patients who have had shoulder repair surgery contract chondrolysis. It didn’t take long for doctors to discover what was causing the painful condition.

“This goes all the way back to about the year 2000. People who had surgery seven or eight years ago who thought they had recovered are now seeing that they’re losing their cartilage and they don’t know why,” Woodson says. “For a long period of time, physicians didn’t know why either. However, now that the literature is expanding and more and more doctors are finding out about this, they’re telling patients to contact attorneys to get advice on what recourse they may have.”

Several cases are set for trial this year. “I think you’re going to see juries return verdicts against these defendants and then others will start to file lawsuits as well,” Woodson says.

SOURCE: Pain Pumps › Why are there so many lawsuits against pain pump manufacturers?

Intra-articular pain pumps

Intra-articular pain pumps are medical devices that hold pain medication. The devices have a tube with a catheter attached to them and that catheter is approved by the Food and Drug Administration (FDA) to be placed in the shoulder tissue for pain relief. The catheter is sort of like a garden hose with holes in it that you place in a flowerbed. Just as water would pass through the garden hose to water plants in the bed, medication is pumped through the catheter of the pain pumps into the shoulder tissue gradually over a 48- to 73-hour period. Once the pain medication has been completely used, the patient is instructed to simply pull the catheter out of his shoulder.

Before pain pumps became available for use, patients were given medication either orally or by injection and would have to be monitored by medical staff. The use of pain pumps allowed patients to go home earlier and require less medical attention post surgery. Used properly, risks associated with pain pumps are minimal and most patients have a relatively good recovery after physical therapy. But then tragedy struck.

“With advice from manufacturers, the pain pump catheters were being placed in the joint space or intra-articular area (as opposed to the joint tissue, as was approved by the FDA) which allowed the pain medication into the joint space,” says Frank Woodson, shareholder with Beasley Allen Law Firm. As a result, “doctors began to see patients suffer severe damage to their shoulder cartilage that we’ve rarely seen before.”

The condition, called chondrolysis, is the loss of cartilage in the joint space and causes extreme pain, loss of motion and in many cases, shoulder replacement. Those who relied on their shoulder strength, found themselves suffering from career-ending injuries.

Approximately 140 lawsuits against manufacturers of pain pumps are currently filed by individuals injured by those pumps. “As patients and physicians learn more about the link between pain pumps and chrondrolysis, I think you’ll see more people come forward,” Woodson says.

SOURCE: Pain Pumps › Pain pump manufacturers knowingly put patients at risk

Almost all torn shoulder labrums require surgery. In the early 2000s, however, surgery often made the injury worse, causing a painful and debilitating condition known as chondrolysis in which the cartilage in the shoulder joint wears away. Chondrolysis causes a decreased range of motion, weakness in the shoulder, and extreme pain. Some patients require shoulder replacement surgery. The resulting condition baffled doctors until they began to make a connection between chondrolysis and the pain pumps used to deliver medication to the wound site following surgery.

The problem was traced to a change in the way the manufacturers of pain pumps advised surgeons to use them. The pumps were approved by the Food and Drug Administration (FDA) with the catheters implanted into the shoulder tissue. Those catheters delivered medication to the area for up to 72 hours. However, pain pump manufacturers began advising doctors to implant the catheters directly into the shoulder joint. As medication dripped into the joint space, it gradually began to eat away at the cartilage, causing a specific type of condition now known as Postarthroscopic Glenohumeral Chondrolysis, or PAGCL.

Once the connection was made, doctors began stopping the practice if implanting the pain pump catheters in shoulder joints and outcomes have improved. While a torn labrum can still end a career, the outcome is much brighter than just a few years ago.

Sources: AZ Snakepit

SOURCE: Pain Pumps › Torn labrum not necessarily career-ending injury

The story focuses on the anesthetic and narcotics used in the devices, which rest outside the body with a catheter that feeds into the wound site. The pain pump allows medication to drip into the surgical area for up to 72 hours following surgery. While the pumps are effective for relieving pain, their use in shoulder surgery has recently come under fire after some patients reported suffering from a debilitating condition known as chondrolysis following use of the pain pumps.

The pain pumps were initially approved for use in shoulder surgery with the catheter implanted in the shoulder tissue, However, in the early 2000s, manufacturers of pain pumps began instructing surgeons to implant the catheters directly into the shoulder joint. The continuous dripping of medication slowly ate away at the cartilage in the shoulder joint, resulting in pain and limited mobility. In some cases, shoulder replacement surgery was required.

A study into the medications used in pain pumps showed that death rate of chondrocytes, or cells found only in the joints, increased with time. Some drug combinations offered worse results. The study’s authors advise caution when using the intra-articular pain pumps for more than 48 hours and to not use medications with epinephrine at all.

“There are still many things that remain unknown about this experiment,” the article says. “Do knee chondrocytes respond differently to these drugs than chondrocytes from the hip or shoulder?” The answers likely lie in more studies to determine the best use of intra-articular pain pumps.

SOURCE: Pain Pumps › Could pain pumps cause problems in knee surgery, too?

One of the complainants, Glen Gore, says a Stryker pain pump was implanted in his shoulder after repair surgery in December 2002. After using the pain pump, he was had lost almost all of the cartilage in his shoulder joint, is unable to raise his arm above shoulder level, and now needs replacement surgery.

Gore is among hundreds of patients who are suing the manufacturer of the pain pumps used in shoulder surgery after the pain pumps caused serious and likely permanent injury to their shoulders. The problem dates back to the early 2000s, when pain pump manufacturers began instructing doctors to place the catheter of the pain pump directly into the shoulder joint. The Food and Drug Administration (FDA) had previously approved its use with the catheter placed in the shoulder tissue but had rejected the manufacturers’ request to have the alternative catheter placement approved, citing the need for studies to ensure the safety.

Placed in the shoulder joint, the catheter dripped medicine that began eating away at the cartilage. Doctors soon began to make the connection between the pain pumps and a condition known as chondrolysis, or specifically Postarthroscopic Glenohumeral Chondrolysis. As a result, pain pump manufacturers like Stryker are facing numerous lawsuits from individuals who have been irreversibly harmed by their product.

Source: Boston.com

SOURCE: Pain Pumps › More lawsuits filed against maker of shoulder pain pumps

The culprit was not the surgery itself but the device used to deliver pain medication to the wound site. Used properly, as approved by the Food and Drug Administration (FDA), the pain pumps were hardly dangerous. But pain pump manufacturers began advising surgeons to use the pain pumps differently, by inserting the catheter directly into the shoulder joint space. Over time, the pain medication was toxic to the cartilage, resulting in chondrolysis.

In 2008, a petition was filed for a multidistrict litigation (MDL) to consolidated the lawsuits pending against the manufacturers of pain pumps. MDLs help coordinate the litigation that is pending in federal courts across the country involving the same allegations or same parties. The Judicial Panel on Multidistrict Litigation decides whether cases should be consolidated under MDL and where to transfer the cases. The judicial panel denied the initial petition requesting an MDL. Many more lawsuits have been filed in federal courts across the country and the panel may revisit its initial decision.

“Denial of the MDL  may be a good thing for patients and consumers because there are already cases that are going to trial,” Woodson says. Several of those cases were settled right before or after the opening statement and others were resolved on a confidential basis in early 2009.

“These are substantial injury cases. This is a very severe injury that should not have occurred,” Woodson says. “Most of these people did not know what occurred to them until they started seeing advertisements from lawyers for these cases. So, that’s the first time that they had any inkling in their mind that there could have been a connection between the use of a pain pump and what’s ultimately happened to their shoulder.

“I’d advise (individuals who believe they may have been injured by the pain pump) that people  see an attorney as soon as possible. ”

SOURCE: Pain Pumps › Pain pump makers may be liable for injury after shoulder surgery

“When you lose someone like that,” Hillman said to The Kansas City Star, “it’s tough to replace. We tried to protect it, and we rested him a couple of times, but it’s just one of those things that needs to be repaired.”

The surgery will end the season prematurely for Crisp, but it shouldn’t hamper his chances for a full recovery. But for hundreds of individuals who had surgery for repairs like a torn labrum in the shoulder, the pain treatment turned out to be more painful and debilitating than the torn labrum itself.

The problem traced back to a pain pump device that is designed to deliver pain medication directly into the shoulder tissue for up to 72 hours following surgery. With the catheter placed in the shoulder tissue, the pumps were effective.

However, in the early 2000s, pain pump manufacturers advised surgeons to place the catheter in the shoulder joint. As the pain medication dripped into the joint rather than the tissue, it began eating away at the shoulder cartilage. The result was a painful condition known as chondrolysis, or specifically Postarthroscopic Glenohumeral Chondrolysis. The condition has caused greater disability and in some cases, shoulder replacement surgery was required.

Hundreds of lawsuits have since been filed against manufacturers of the pain pumps. Patients who have used a pain pump to regulate pain following shoulder, knee, hip, ankle or back surgery, should consult their doctor if they experience continued pain; weakness in the shoulder; clicking, popping or grinding in the shoulder; or a decreased range of motion. Individuals who have been injured by an intra-articular pain pump may have a claim against the manufacturers.

SOURCE: Pain Pumps › Coco Crisp to undergo season-ending shoulder surgery

Kansas City Royals

Crisp, who has not played since June 12, was put on the disabled list and restricted from all swinging and throwing activities. “Obviously, that’s not a good sign,” says general manager Dayton Moore.

Once thought of as a career-ending injury, torn labrums can be repaired and one’s throwing ability restored. Recovery usually takes several weeks. It also can be considered a safer procedure than in years past, when the device used to alleviate pain following surgery ended up causing more damage and, in many cases, rendering the shoulder useless.

Intra-articular pain pumps are devices that are approved by the Food and Drug Administration (FDA) to deliver medication through a catheter placed directly into the tissue near the wound site. In the early 2000s, pain pump manufacturers asked the FDA if the catheters could be placed directly into the shoulder joint rather than the tissue. The FDA said no; more testing would be required.

Instead of working the proper channels to get the alternative use approved, pain pump manufacturers began advising surgeons to place the catheters into the shoulder joint. As a result, patients began suffering from a condition known as chondrolysis. Chondrolysis is the disappearance of cartilage in the shoulder resulting in joint narrowing and stiffness. In some cases, shoulder replacement may be necessary.

The improper use of pain pumps has ceased, but those injured by the devices are just beginning to experience problems and as a result numerous lawsuits have been filed against the manufacturers of pain pumps.

SOURCE: Pain Pumps › Royals’ Crisp may need shoulder surgery

The labrum is a cartilage found in the shoulder’s ball-and-socket joint where the arm meets the body. It serves to deepen the socket so that the ball stays in place and helps stabilize the arm. When the labrum is torn due to injury, the ball may slide part or all of the way out of the socket. Symptoms of a labral tear depend on where the tear is located, and may include an aching sensation in the shoulder joint, catching of the shoulder when moved, and pain during physical activity.

Treatment for a torn labrum depends on the type of tear. They often do not require surgery; however, patients with persistent symptoms that do not respond to other therapies may need surgery. Recovery from surgery usually depends on where the tear occurred and how severe the tear was. Typically, it takes four to six weeks for the labrum to re-attach itself to the rim of the bone and another four to six weeks to strengthen and fully heal.

A majority of patients regain full functioning of their shoulder after labrum repair, but that was not always the case. Just a few years ago orthopedic surgeons began seeing more and more patients suffering from a painful and debilitating condition known as chondrolysis in patients who had had shoulder surgery. The condition was traced back to pain pumps used to deliver medication to the shoulder joint for up to 72 hours after surgery.

An investigation found that pain pump manufacturers were advising doctors to insert the pump catheters directly into the shoulder joint rather than the tissue, as was approved by the Food and Drug Administration (FDA). As a result, more than 140 lawsuits have been filed in state and federal court against manufacturers of pain pump devices.

Source: Johns Hopkins Medicine

SOURCE: Pain Pumps › Recovery more likely after shoulder surgery than in years past

Labrum repair surgery requires months to heal because the fibrocartilage has a poor blood supply. During surgery, the labrum is stitched together and anchored to the bone. It generally takes about six months for the tissue to heal. Typically, surgeons perform authroscopic surgery to repair shoulder injuries in patients and often use pain pumps to help alleviate pain for up to 72 hours following surgery. Pain pumps offer an alternative to narcotics and pain killers; however, misinformation about how the pain pumps should be used provided by pain pump manufacturers years ago have resulted in debilitating – and for some athletes, career-ending – injury to the shoulder joint.

The injuries stem from a change in the way pain pump manufacturers began to market the devices to surgeons, according to Frank Woodson, shareholder for Beasley Allen Law Firm. When the pain pumps were originally approved by the Food and Drug Administration (FDA), the pump’s catheter was to be placed in the shoulder tissue. However, in the 1990s and early 2000s, pain pump manufacturers began advising surgeons to place the pain pump catheters in the joint space, or intra-articular area, allowing pain medication to go directly into the joint space. This use had not been approved by the FDA. Shortly after the pumps were used in the inappropriate manner, per the advice of the pain pump manufacturers, “doctors began to see patients suffer severe damage to their shoulder cartilage that we’ve rarely seen before,” Woodson said.

What resulted was the loss of cartilage, or joint space, commonly called chondrolysis. It leads to severe pain because the cartilage in the shoulder space is gone, causing bones to rub together. As the condition progresses, patients may require shoulder replacement and it makes normal daily activities painful and difficult.

There are approximately 140 lawsuits filed by people who have been injured by misuse of these pain pumps. All are pending in state and federal courts throughout the country. “There are many more cases under review across the country and there will likely be many more filed,” Woodson said. “As patients and physicians learn more about the link between pain pumps and chrondrolysis, I think you’ll see many more people come forward.”

Source: Google: AFP

SOURCE: Pain Pumps › Magic’s Nelson plays just months after shoulder surgery

The nine are among a growing number of lawsuits filed against the makers of shoulder pain pumps that were used in patients following shoulder surgery. The devices have a catheter that is implanted into the surgical site and delivers regular does of anesthetics to the wound for up to 72 hours. Doctors soon began to see a connection between the use of the devices and a painful and debilitating condition known as chondrolysis.

The pain pumps were approved by the Food and Drug Administration (FDA) with the catheters placed in the shoulder tissue, but in the 1990s pain pump manufacturers sought approval from the FDA to have the catheters placed directly in the shoulder joint.

“To the FDA’s credit, they said no,” says Frank Woodson, shareholder with Beasley Allen Law Firm. “The FDA said, ‘If you want permission to do that, you’re going to have to do safety studies to determine whether or not that is a safe practice or a safe method to use your product.’ The companies did not do that and just went ahead and started advising physicians to place the pain pump catheter in the joint space.”

When the catheters were placed in the shoulder joint instead of the tissue, the medication began to eat away at the cartilage in the joint, causing the painful condition known as chondrolysis.

As a result, more than 140 lawsuits have been filed in state and federal courts against manufacturers of pain pump devices. “I hope this litigation will continue to educate the medical community to use pain pumps in a proper manner because if it is done in that way, then we should stop seeing these injuries occur,” Woodson said.

SOURCE: Pain Pumps › Lawsuits seek more than $68 million from pain pump manufacturers

Zone maintains that the cover of I-Flow’s On-Q pain pump contains holes that allow latex to come in contact with patients and health care professionals. The company contends that individuals who come in contact with the pump and suffer a latex reaction may not be properly treated based on the assumption that the I-Flow product does not pose a latex risk. Zone is the worldwide distributor for the Solace pain pump, which has a latex-free design.

I-Flow may want to take a closer look at patient safety. The company is one of several pain pump manufacturers – a list that also includes Stryker Corporation, DJ Orthopedics Inc., and Breg Inc. – facing lawsuits from plaintiffs that allege the pumps have caused lifelong and painfully debilitating shoulder injury. Lawsuits contend that manufacturers of pain pumps instructed physicians to use the pumps in a manner that was not approved by the FDA for shoulder surgery.

Instead of implanting the catheter of the pain pumps into the shoulder tissue as was FDA approved, surgeons were instructed to place the catheters into the shoulder joint area. Doing so allowed medication to drip into the shoulder joint and essentially eat away the cartilage, causing bone to rub against bone and resulting in a serious, irreversible condition known as chondrolysis.

Source: PR Web

SOURCE: Pain Pumps › I-Flow pain pump manufacturers face more lawsuits

The company’s Regional Anesthesia sales, which includes the company’s flagship On-Q product lines, also increased 9 percent during the same quarter, according to the report.

There are approximately 140 lawsuits against manufacturers of pain pumps, including I-Flow Corporation, currently pending in state and federal courts throughout the country, says Frank Woodson, shareholder with Beasley Allen Law Firm. That number has jumped considerably since the summer of 2008, as more and more evidence began to link pain pumps to a serious and debilitating shoulder injury known as chondrolysis.

Pain pumps are commonly used by surgeons when performing shoulder surgeries. The pump, which sits outside the body but is attached to a catheter that is implanted into the surgical site, delivers medication for up to 72 hours. Once all the medication has been injected, the catheter is gently pulled out by the patient.

Pain pump manufacturers were given Food and Drug Administration (FDA) approval to market the devices with the catheter in the shoulder tissue. In early 2000, manufacturers sought to have FDA approval to put the catheters directly into the shoulder joint but the FDA rejected the request. However, pain pump manufacturers went ahead and instructed physicians to implant the catheter in the shoulder joint. The medicine that dripped into the shoulder joint area ate away the cartilage in the shoulder joint causing the painful and debilitating condition known as chondrolysis. There is no cure for the condition and in some cases, more surgery may be required.

SOURCE: Pain Pumps › Pain pump manufacturer enjoys gains despite mounting lawsuits

Pain pumps are devices that hold pain medication that is gradually released into the shoulder tissue through a catheter implanted in the surgical site. Once the pain medication has been released into the joint, the catheter is removed by the patient. When used properly, pain pumps offer a convenient alternative to oral or intravenous painkillers for those undergoing shoulder surgery. And most patients can expect a good recovery following physical therapy.

However, in the late 1990s manufacturers of pain pumps sought FDA approval to have the catheters placed directly in the joint area, rather than the shoulder tissue. “To the FDA’s credit, they said no,” says Frank Woodson, shareholder with Beasley Allen Law Firm. “The FDA said, ‘If you want permission to do that, you’re going to have to do safety studies to determine whether or not that is a safe practice or a safe method to use your product.’ The companies did not do that and just went ahead and started advising physicians to place the pain pump catheter in the joint space.

“They never studied it and they never obtained FDA approval,” he says. As a result, physicians began seeing their patients with a debilitating condition called chondrolysis, or a narrowing of the cartilage. As the cartilage begins to wear away, bone rubs against bone causing pain and disability. In many cases, shoulder replacement is required.

Approximately 140 lawsuits have been filed in state and federal courts against manufacturers of pain pump devices and several cases are set for trial in 2009. “I hope this litigation will continue to educate the medical community to use pain pumps in a proper manner because if it is done in that way, then we should stop seeing these injuries occur,” Woodson said.

SOURCE: Pain Pumps › FDA told pain pump manufacturers ‘no,’ but they refused to listen

“I think what we’re seeing is that physicians are finally seeing the relationship between pain pumps and chondrolysis – especially since the first lawsuits were filed a couple years ago,” he says. “In addition, literature is now being published about the connection between the pumps and chondrolysis. So, the more information that becomes available, the more people are learning what may be causing their shoulder problems.”

The problem traces back to about the year 2000, when pain pump manufacturers began advising physicians to place the device’s catheter into the joint space, or intra-articular area. The catheters were intended and approved by the Food and Drug Administration (FDA) to be placed into the shoulder tissue, and not the joint space. As a result, medicine was feeding directly into the joint space causing the cartilage to gradually wear away. This narrowing of the cartilage, called chondrolysis, causes severe pain and disability. There is no cure for the condition and many individuals are faced with lifelong disability as a result.

Recently, a study published by The American Journal of Sports Medicine identified intra-articular pain pumps as the likely cause of chondrolysis.

“People who had surgery seven or eight years ago who thought they had recovered are now seeing that they’re losing their cartilage and they don’t know why,” Woodson says, adding that several cases are set for trial in 2009. “I think that you’re going to see juries return verdicts against these defendants and then others will start to file lawsuits as well.”

SOURCE: Pain Pumps › More lawsuits filed as link made between pain pumps, chondrolysis

However, in the 1990s and early 2000s, pain pump manufacturers began to market the product differently, according to Beasley Allen shareholder Frank Woodson. “The catheter was intended and approved by the FDA to be placed into the shoulder tissue. (But) with advice from manufacturers, the pain pump catheters were being placed in the joint space or intra-articular area, which allowed the pain medication into the joint space.”

By advising surgeons to use the pump in such a manner – one that had never been approved by the FDA – tragedy ensued. “Doctors began to see patients suffer severe damage to their shoulder cartilage that we’ve rarely seen before,” Woodson said.

What resulted was the loss of cartilage, or joint space, commonly called chondrolysis. It leads to severe pain because the cartilage in the shoulder space is gone, causing bones to rub together. As the condition progresses, patients may require shoulder replacement and it makes normal daily activities painful and difficult.

There are approximately 140 lawsuits filed by people who have been injured by misuse of these pain pumps. All are pending in state and federal courts throughout the country. “There are many more cases under review across the country and there will likely be many more filed,” Woodson said. “As patients and physicians learn more about the link between pain pumps and chrondrolysis, I think you’ll see many more people come forward.”

SOURCE: Pain Pumps › Pain pump manufacturer’s bad advice leads to ‘tragedy’

The On-Q PainBuster pain pump offers an alternative to traditional intravenous and oral painkillers, which can leave patients feeling groggy. The pain pump uses a small balloon that holds a local anesthetic that is fed through a thin antimicrobial catheter that is inserted into the surgical site. The device injects the pain relief medication directly to the surgical site on a continuous basis for up to 72 hours following surgery. Following surgery, the patient goes home with the implanted device and after two or three days, the patient gently pushes out the catheter and discards the device.

Doctors who have used the pain pumps for hysterectomies and C-sections say the device helps women get up and about faster than using more traditional pain meds.

The I-Flow On Q PainBuster pain pumps have been a popular choice for orthopedic surgeons performing knee and shoulder surgeries. The pain pumps are designed and intended to be used with anesthetics that are administered continuously over time.

However, in shoulder surgeries in particular, the medication delivered directly to the surgery site has caused serious and permanent damage to the cartilage of the shoulder joint. This narrowing of the joint space is known as chondrolysis, a condition in which the complete or nearly complete loss of cartilage in the shoulder joint. Chondrolysis is an irreversible disabling and extremely painful condition.

A recent study published by The American Journal of Sports Medicine identified these intra-articular pain pumps as the likely cause of chondrolysis in shoulders.

There do not appear to be any reported problems with pain pump use following C-sections and hysterectomies at this time.

SOURCE: Pain Pumps › Pain pumps used following C-sections, hysterectomies

Astros

“It gives me a little peace of mind to go get (the surgery),” Hall told the Chronicle. “Seeing the MRI and seeing what I’ve been dealing with the last couple of years, it kind of puts me at ease to go get it fixed. That way I can get back out there (as) the player that I used to be and be healthy (and) go out there with two labrums.”

The labrum is located in the ball-and-socket joint of the shoulder. Since the shoulder socket is very shallow, a cuff of cartilage called the labrum allows the arm bone to move within the shoulder socket, giving it more stability and range of motion. The labrum, however, is susceptible to injury. Most labrum tears do not require surgery, but patients with persistent symptoms after trying other treatments unsuccessfully may need surgery to correct the problem.

Shoulder surgery often requires the use of pain pumps for post-operative pain management. The pain pump is implanted into the shoulder joint during surgery and delivers a steady amount of medication to the wound site.

A recent study published in The American Journal of Sports Medicine identified post operative pain pumps, or intra-articular pain pumps, as a likely cause of Postarthroscopic Glenohumeral Chondrolysis, a debilitating condition in which the cartilage in the shoulder joint breaks down, causing the bones in the shoulder to rub together. The condition can cause chronic pain and can limit mobility. Additional surgeries may be required.

The Astros will void Hall’s minor-league contract, as he will be out at least four months for surgery as opposed to just one month if he had tried rehab without surgery.

SOURCE: Pain Pumps › Astros Toby Hall opts for shoulder surgery to correct torn labrum

Osteoarthritis is a common aliment that has earned the condition a top ranking in disability of Americans. Symptoms of stiffness, pain and limited movement are caused when the cartilage at the end of the bone breaks down, causing the bones to rub together at the joints. The most common remedy has been arthroscopic surgery, during which surgeons insert a scope with a camera through small incisions, where they smooth damaged cartilage surfaces and flush out bone chips. This allows for faster healing time than traditional surgery.

To alleviate pain following knee surgery, doctors at times will insert a pain pump to deliver medication directly to the surgical wound site. These post-operative pain pumps can help alleviate the pain associated with surgery, but they may come at a greater risk. Post-operative pain pumps, or intra-articular pain pumps, are routinely used in similar arthroscopic surgeries for shoulder injuries.

A recent study by The American Journal of Sports Medicine identified a link between the post-operative pain pumps and a painful, cartilage deteriorating condition known as Postarthoscopic Glenohumeral Chondrolysis, or PAGCL. PAGCL can cause irreversible damage and may require additional surgeries.

Patients who are considering knee surgery are advised to discuss alternative options with their physicians.

SOURCE: Pain Pumps › Studies show medication, physical therapy as effective as knee surgery

A torn labrum flap is an injury to the part of shoulder joint. Having the surgery could likely end the season for Francis. Though he is a month behind on his throwing program, he says he will continue to pitch and hope that he can work past the shoulder discomfort.

Perhaps one reason Francis hopes to avoid surgery is that shoulder surgery often requires a pain pump for post-operative pain management. The pump is implanted into the shoulder joint during surgery and delivers a steady amount of medication to the surgery wound site. This is often a preferred alternative to narcotics and pain-killers, which can have negative side effects.

However, post-operative pain pumps recently have been associated with a painful condition known as Post-arthoscopic Glenohumeral Chondrolysis , or PAGCL, in which the cartilage in the shoulder joint break down, causing the bones to rub against each other. The damage can occur rapidly. PAGCL is believed to be irreversible and may require extensive surgeries.

The symptoms of PAGCL can begin to develop as early as two months after surgery up to a year following the procedure. Symptoms of PAGCL include decreased mobility and range of motion; constant pain both at rest and in motion; shoulder stiffness and/or weakness; and popping, clicking, grinding noise in the shoulder. Those who experience symptoms are encouraged to contact their physicans.

SOURCE: Pain Pumps › Shoulder surgery decision weighs on Rockies’ Jeff Francis

The study analyzed data from the 2005-2007 National High School Sports Injury Surveillance System and showed that shoulder injuries made up 18 percent of all injuries caused during both baseball and wrestling, and 12 percent of injuries caused during football. The report identified that shoulder injuries were three times more likely to occur during competition.

Overall, six percent of shoulder injuries required surgery. The sport that caused more surgeries to shoulders was wrestling. When shoulder surgeries are performed, they most often require the use of a pain pump to deliver medication directly to the surgical site for post operative pain management.

However, these post-operative pain pumps, also known as intra-articular pain pumps, can cause severe problems in some patients. Many patients who have used pain pumps have suffered from Postarthroscopic Glenohumeral Chondrolysis, (PAGCL) a painful condition that occurs in the shoulder when the cartilage between the ball and socket of the shoulder breaks down causing the bones to rub against each other.

Individuals who have used a pain pump to manage pain following shoulder surgery – or any other joint-related surgery – should consult their physician if they experience continued pain; weakness; clicking, popping or grinding; or decreased range of motion.

SOURCE: Pain Pumps › Study: Shoulder injuries happen more often to high school boys than girls

Post-operative pain pumps are a pain-management system that deliver medication directly to the surgical wound. The pumps came under fire recently after The American Journal of Sports Medicine linked intra-articular (or post-operative) pain pumps to cases of Postarthroscopic Glenohumeral Chondrolysis, a progressive degeneration of the cartilage in the shoulder resulting in pain and loss of motion. Chondrolysis is a chronic condition that often requires surgery.

Until the 1990s, the pumps delivered medication at a limited flow rate. In the late 1990s, manufacturers increased the amount of anesthetic used in the pain pumps. The lawsuit contends that continuous injection of the high-volume anesthetics into the shoulder can cause serious and permanent damage to the joint cartilage in the shoulder. The lawsuit also claims the pumps were marketed without first doing studies to determine the safety of the high-volume pain pumps or what damage could have occurred, instead encouraging use of both the pain pumps with the high doses of anesthetics.

“The plaintiffs are demanding compensatory damages for fraudulent misrepresentation, negligent misrepresentation negligence, strict liability, and breach of warranty,” according to the report.

SOURCE: Pain Pumps › Pain pump manufacturers named in lawsuit

Postoperative pain pumps are a pain-management system designed to deliver medication directly to the surgical wound or in close proximity to the nerves associated with the surgical area. A recent study published by The American Journal of Sports Medicine identified the post-operative pain pumps as the likely cause of articular chondrolysis, a progressive degeneration of the cartilage. Chondrolysis of the shoulder results in the narrowing of the joint space, which can cause pain and loss of motion. Chondrolysis is a chronic condition that often requires surgery.

As of July 2008, Health Canada had received eight reports of articular chondrolysis one month to one year following shoulder surgery. In all cases, the chondrolysis was thought to have been related to pain pumps. All patients listed in the incidence reports received bupivacaine, a local anesthetic, with epinephrine, a hormone and neurotransmitter.

Instructions for use on the label of the postoperative pain pumps discourages continuous intra-articular infusion of anesthetics, particularly when epinephrine is used.

In its announcement, Canada Health also urged health care professionals to report any adverse incidents following the use of pain pumps or other medical devices to the Health Products and Food Branch Inspectorate through the Inspectorate Hotline at 800-267-9675.

SOURCE: Pain Pumps › Health Canada issues warning about postoperative pain pumps

Once the pain pumps were removed, the officer continued to have stiffness, but only in her left shoulder. The continued stiffness and pain caused her to have two additional surgeries on her left shoulder, hoping these surgeries would be the end to her shoulder problems. But when the second surgery was performed, the doctors noticed that the articular cartilage in her shoulder was nearly gone. Even after the second surgery, her left shoulder was still stiff and still in pain.

A physical examination was given to the officer post surgeries to test the flexibility and rotation of her shoulders. The difference between the movement of the right and left shoulder was staggering. The right shoulder (the one in which the pain pump leaked) had 140 degrees of forward elevation, 60 degrees of external rotation and internal rotation of T12. The left shoulder was extremely stiff and only had a 30 degree arc of rotation and flexion/extension.  Even if you do not understand medical jargon, these numbers are quite different.

The officer was given multiple cortisone injections, five viscosupplementation injections, physical therapy and narcotics, all of which did nothing to alleviate her pain and stiffness.  With little hope of her left shoulder ever being the same, the officer is currently considering her options of what to do next.

The article from UW Medicine, a publication of the Univeristy of Washington School of Medicine, shows in this particular case how the right shoulder that did not receive the pain medication did not show any problems post surgery. However, the left shoulder that did receive the pain medication is left with little to no cartilage and stiffness that might not ever go away. With her symptoms, the officer may suffer from Postarthroscopic Glenohumeral Chondrolysis (PAGCL), an extremely painful condition involving the deterioration of cartilage in the shoulder joint.

PAGCL has been linked to numerous cases where pain pumps were inserted after shoulder surgeries and is the most common complication following should surgeries, according to The American Journal of Sports Medicine. Unfortunately, the only treatment for PAGCL is more surgeries, and they cannot be arthroscopic.

When and if you decide on shoulder surgery, know the risks and outcomes of using a pain pump. A small device used to alleviate pain post surgery may result in more surgeries and never-ending shoulder problems.

SOURCE: Pain Pumps › Pain pump malfunction saves officer’s right shoulder

Shoulder arthroscopy is a rapidly expanding field because it offers a less invasive and less painful option for patients. In arthroscopy, two very small incisions are made, one for instruments and one for a miniature surgical camera to allow the surgeon’s viewing of the area without a large surgical site.

To manage post-surgical pain and extend the deployment of numbing agents, the use of temporary intra-articular shoulder pain pumps was introduced into these types of surgeries.

The procedure involves placing a flexible intra-articular shoulder pain pump catheter into the shoulder joint with the pump remaining in the joint for several days to deliver controlled doses of pain medication, often a combination of bupivacaine and epinephrine. This course of treatment became popular because it reduced recovery time without the need for narcotic pain relievers.

But a few days of relief can result in a debilitating and lifelong condition that causes severe-and often, permanent-pain and mobility loss and the need for constant medication. In some patients, complete loss of the use of the shoulder occurs.

PAGCL, one of the most common complications from shoulder surgeries is a condition where overwhelming damage to the shoulder occurs when cartilage deteriorates following these types of arthroscopic procedures. Without cartilage, there is no bone-to-bone cushion, causing bones to grind together and resulting in intense pain and, in some cases, chronic arthritis.

A study of 152 patients who underwent arthroscopic shoulder surgeries revealed that 12 of the patients developed PAGCL. All 12 PAGCL patients received pain pumps during their surgeries; the use of the pain pump was the only factor that the PAGCL patients had in common. In fact, studies suggest that up to 63% of arthroscopic shoulder surgery patients who received an intra-articular pain pump are at risk for developing PAGCL.

In addition to living with acute pain and daily medication, PAGCL may result in a need for follow-up surgery. Unfortunately, arthroscopic surgery is not an option. The damage that occurs with PAGCL requires the more painful and invasive shoulder joint replacement surgery (arthroplasty), a more intense surgery option over arthroscopy. Arthroplasty involves replacing the joint with plastic and metal components. Surgery lasts two and three hours and patients usually remain in the hospital for three nights. Physical therapy is almost always required following this type of procedure. Despite surgery, many patients never fully regain use of their joint and some patients report increased pain.

No consistently successful PAGCL treatment has emerged and the damage from PAGCL is believed to be irreversible. Unfortunately, pain medications seem to worsen the symptoms of PAGCL and offer no long-term value concerning treatment or cure.

PAGCL tends to develop two to twelve months following surgery. Symptoms include shoulder pain, whether in motion or at rest; increased shoulder stiffness; popping or grinding when the shoulder is in motion; decreased to full loss of range of motion; and loss of joint strength. Diagnosis of PAGCL is confirmed via an x-ray indicating narrowing of the shoulder joint space and indicating additional surgery is required to replace the destroyed joint.

November 15th, 2007

SOURCE: Pain Pumps › Shoulder pain pumps can result in lifetime disability

These devices have been used on thousands of patients nationwide, and based on our findings, hundreds appear to be at risk for this complication which results in severe pain, debilitating stiffness and eventual joint replacement surgery for many of those affected. We sent the results of our study to the manufacturers more than two years ago, but their response has so far been minimal to non-existent. It is time to get the word out and stop these devices from ruining any more lives.
Dr. Beck’s warning comes at an appropriate time now that football season is in full swing. Manufacturers report that the number of orthopedic surgeries rise sin the fourth quarter of each year tied to increased sports activity, particularly football and skiing. It appears that patients may tend to defer elective surgeries until the fourth quarter after annual insurance deductibles are satisfied.

The article, published in the October 2007 issue of The American Journal of Sports Medicine, demonstrates a strong association between the intra-articular (inside the joint space) use of high volume pain pumps following arthroscopic shoulder surgery and an otherwise unexplainable loss of hyaline cartilage in the shoulder joint. Dr. Brent Hansen, an orthopedic surgeon, was the senior author of the study. The complication discussed in the article, known as Postarthroscopic Glenohumeral Chondrolysis (PAGCL), is permanent and can lead to extreme pain and lifelong suffering in 63% of the patients that use the pain pumps. It is suggested that the complications may occur following open surgery as well.

Numerous lawsuits are pending against the companies that manufacture, market, or distribute the pain pumps, including Stryker, DJO Inc., I-Flow Inc., BREG Inc. and others. Included among the many claims in the lawsuits are the allegations that the manufacturers failed to instruct or warn the U.S. medical community that the safety of using the pain pumps in the shoulder joint space had not been established or that the continuous injections of commonly used anesthetics may cause permanent injury.

Our firm is looking into a number of claims from people across the country whose lives have been devastated by these pain pumps. These are supposed to be routine outpatient procedures, but the patients often endure several more surgeries, and most will eventually need complete shoulder replacement. We expect hundreds of individuals across the country to come forward with their own stories of ongoing pain and suffering they have experienced after using one of these devices. Frank Woodson, who is in our Mass Torts Section, is heading up a team that is investigating cases that include the use of pain pumps, not only in the shoulder, but in the knee, ankle and hip. If you need additional information relating to this matter, you can contact Frank at (334) 269-2343.

Source: Associated Press

November 15th, 2007

SOURCE: Pain Pumps › Pain pumps can cause cartilage damage